Quality Blog

MDR (EU) 2017/745 is a set of regulations that govern the European medical device market. It was created […]

Check out our latest video and let us know what you think!

We’ve used 5W2H to discuss Product Quality Control before, and now we’re using this popular tool to provide […]

I’ve recently returned from a visit to our offices in China where I was able to attend a […]

Our recent newsletter Feature Article highlighted ISO 13485 audits applicable to the medical device industry.  A common question […]

ISO 13485:2003 is a standard issued by the International Organization for Standardization that specifies requirements for a medical […]

Although the program started in 2001, there continues to be a lack of understanding regarding what C-TPAT is […]

We saw this video posted recently and thought it was such an excellent introduction to audits that we […]

A previous Quality Q & A newsletter article featured tips for audit preparation.   In the reprinted content below, […]